DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 136, 140-143, 145-151, 155, 157-159, 162 and 163 are rejected under 35 U.S.C. 103 as being unpatentable over Nowak USPGPub 20200061022.
Regarding claims 136, 145-148, 162 and 163, Nowak teaches a powder composition [0018] consisting of
one or more isolated cannabinoids [0019]
one or more triglyceride solubilizing agents such as hydrogenated vegetable oil [0020,0025,0062]
optional silicon dioxide [0048] (a filler and or texturizer)
intra-granular excipient selected from, inter alia, diluents such as sucrose, isomalt, mannitol and sorbitol or binders such as sugars, all of which are sweeteners [0046-0047]
Nowak is silent regarding the precise proportions or ratios of components recited in claims 136, 145, 147,148, 162 and 163, however, the disclosure of the presence of these ingredients encompasses proportions that range from 0% to 100% less the proportion of other components. As such, the disclosure of Nowak encompasses embodiments having the proportions and ratios of components recited in claims 136, 145, 147,148, 162 and 163. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) Additionally, It would have been obvious to one of ordinary skill in the art at the time the application was filed to have balanced the proportions of ingredient in the powder of Nowak to ensure efficient granulation. Therefore, the limitations of claims 136, 145-148, 162 and 163 are rendered obvious by Nowak.
Regarding claims 140 and 141, the oils of Nowak are blends of triglycerides that are liquid at or above 0 degrees C. [0062]
Regarding claims 142 and 143, although Nowak does not disclose the processing conditions recited in claims 142 and 143, it is noted that “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) . Further, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113.
Therefore, absent evidence of criticality regarding the presently claimed temperatures and order of combining ingredients and given that Nowak teaches a composition as claimed, the composition of Nowak clearly meets the requirements of present claims 142 and 143.
Regarding claims 149 and 150, Nowak teaches THC and CBD. [0019]
Regarding claim 151, it would have been obvious to one of ordinary skill in the art at the time the application was filed to have employed THC or CBD concentrates having the highest purity available in order to avoid adulterants.
Regarding claim 155, the composition of Nowak is ready to use.
Regarding claims 157-159, Nowak teaches forming tablets from the composition disclosed. [0077] Nowak teaches that the powders disclosed can be blended with extra-granular excipients and processed into a dosage form. The disclosure of Nowak encompasses proportions of the powder as recited in claim 158. . In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)
Claims 137, 138 and 144 are rejected under 35 U.S.C. 103 as being unpatentable over Nowak USPGPub 20200061022 in further view of Marten “Medium-chain triglycerides”, Internatl. Dairy Jour. 16 (2006) 1374–1382.
Regarding claims 137, 138 and 144, Nowak teaches what has been recited above but is silent regarding the triglycerides recited in claims 137, 138 and 144.
Marten teaches “The term medium-chain triacylglycerols refers to mixed triacylglycerols of saturated fatty acids with a chain length of 6–10 carbons, i.e., hexanoic acid (C6:0, common name capronic acid), octanoic acid (C8:0, common name caprylic acid), and decanoic acid (C10:0, common name capric acid). Sometimes, dodecanoic acid (C12:0, common name lauric acid) is included.” (Sec. 1) MCTs produced from coconut oil contain almost exclusively octanoic and decanoic acid, at a ratio from 50:50 to 80:20. (Sec. 2) Marten states “In a number of studies, but not always, beneficial effects of MCTs on weight control and glucose as well as on lipid metabolism were observed. This may prove the usefulness of natural foods containing relatively high amounts of MCFAs as well as the usefulness of functional foods supplemented with MCTs.” (Sec. 8)
Nowak and Marten are both directed to compositions comprising coconut oil. It would have been obvious to one of ordinary skill in the art at the time the application was filed to have substituted MCT oil derived from coconut oil as the solubilizing agent in Nowak since coconut oil was identified by Nowak as a suitable solubilizing agent and Marten teaches that MCTs are useful ingredients in food for their health benefits. This obvious modification of Nowak with Marten renders obvious the limitations of claims 137, 138 and 144.
Response to Arguments
Applicant's arguments filed 9 March 20206 have been fully considered but they are not persuasive.
Applicant asserts on page 7 of the remarks that the rejection relies on impermissible “picking and choosing” from different portions of the disclosure of Nowak. This assertion is an inaccurate characterization of the instantly pending rejection. The rejection relies on the identification of embodiments encompassed by the disclosure of Nowak. While applicant has generically asserted the relevance of the Rolls-Royce and Leo Pharma. Case law, applicant has failed to identify how the fact patterns in those cases are relevant to the instantly pending rejection. Instead, attention should be drawn to MPEP 2131.02 which states “A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015)” While this case law is directed to anticipation, given that anticipation is the highest form of obviousness, it is clear that the “at once envisage” standard is relevant to the consideration of obviousness. The instantly pending rejection relies on “choosing” elements from different categories of the components that make up the invention of Nowak. As stated in MPEP 2144.07 “The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. (“Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious))” As such, applicant’s assertion is not found persuasive.
Applicant attempts to extend their reasoning regarding picking and choosing further on pages 7 and 8 of the remarks by asserting that Nowak teaches other optional components and therefore Nowak cannot render obvious claims consisting only of the claimed components. However, “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
Applicant asserts on page 8 of the remarks that “unpredictable” choices would be required to arrive at the claimed invention from the disclosure of Nowak. Applicant fails to identify which choices would be unpredictable or provide an explanation of why it would be unpredictable to utilize components explicitly disclosed by Nowak to be suitable for use together. The “omission” of emulsifier/surfactant from Nowak is not required in the instantly pending rejection as there is no requirement in Nowak that such additional compounds are required to be present.
Applicant asserts on page 9 of the remarks that while the MPEP states “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”, this case law is only relevant when the prior art explicitly discloses a range. It is unclear what legal standard applicant is applying in making this assertion. Prior art references are considered for all that they would fairly teach to one of ordinary skill in the art. In the absence of explicit quantities, one of ordinary skill would clearly understand that the Nowak reference encompasses all proportions of the disclosed ingredients. As such, applicant has failed to rebut the prima facie case of obviousness set forth.
Applicant asserts on pages 9 and 10 of the remarks that because the motivation provided by the examiner is implicit that it is impermissible. However, the Courts have made clear that the teaching, suggestion, or motivation test is flexible and an explicit suggestion to combine the prior art is not necessary. The motivation to combine may be implicit and may be found in the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved. DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., at 1366, 80 USPQ2d at 1649 (Fed. Cir. 2006). “[A]n implicit motivation to combine exists not only when a suggestion may be gleaned from the prior art as a whole, but when the improvement is technology-independent and the combination of references results in a product or process that is more desirable, for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient. Because the desire to enhance commercial opportunities by improving a product or process is universal-and even common-sensical-we have held that there exists in these situations a motivation to combine prior art references even absent any hint of suggestion in the references themselves. In such situations, the proper question is whether the ordinary artisan possesses knowledge and skills rendering him capable of combining the prior art references.” Id. at 1368, 80 USPQ2d at 1651. (MPEP 2143 (G))
It is further noted that applicant has not asserted or demonstrated any criticality to the claimed proportions. Attention is invited to In re Levin, 84 USPQ 232 and the cases cited therein, which are considered in point in fact situation of the instant case. At page 234, the Court stated as follows:
This court has taken the position that new recipes or formulas for cooking food which involve the addition or elimination of common ingredients, or for treating them in ways which differ from the former practice, do not amount to invention, merely because it is not disclosed that, in the constantly developing art of preparing food, no one else ever did the particular thing upon which the applicant asserts his right to a patent. In all such cases, there is nothing patentable unless the applicant by a proper showing further establishes a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected and useful function. In re Benjamin D. White, 17 C.C.P.A. (Patents) 956, 39 F.2d 974, 5 USPQ 267; In re Mason et al., 33 C.C.P.A. (Patents) 1144, 156 F.2d 189, 70 USPQ 221.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michele L Jacobson whose telephone number is (571)272-8905. The examiner can normally be reached Monday through Friday from 10-6.
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/Michele L Jacobson/Primary Examiner, Art Unit 1793